A Phase 2, Study of Ficlatuzumab Plus Erlotinib vs. Placebo Plus Erlotinib in Subjects With Previously Untreated Metastatic, EGFR-mutated NSCLC and BDX004 Positive Label

NCT02318368 | Terminated Phase 2 Results

• 1 other identifier: AV-299-14-206
• Study Type: interventional
• Target: 10
• Locations: 7 countries
• Sites: 47

Brief Summary

Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression Free Survival is defined as the time from the date of randomization to the date of the first objective documentation of radiographic disease progression or death due to any cause, whichever occurs first.

  Approximately 24 months

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  Approximately 24 months

Study Arms (2)

Ficlatuzumab plus erlotinib

EXPERIMENTAL

150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with 20 mg/kg Ficlatuzumab administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.

Drug: Ficlatuzumab; Drug: Erlotinib

Placebo plus erlotinib

ACTIVE COMPARATOR

150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with Placebo administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.

Drug: Erlotinib; Drug: placebo

Interventions

Ficlatuzumab DRUG

Also known as: Ficla

Ficlatuzumab plus erlotinib

Erlotinib DRUG

Also known as: Erlotinib hydrochloride

Ficlatuzumab plus erlotinib; Placebo plus erlotinib

placebo DRUG

Placebo plus erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically and/or cytologically confirmed primary diagnosis of Stage IV NSCLC (according to American Joint Committee on Cancer \[AJCC\] 7th edition lung cancer staging criteria).
• Measurable disease according to RECIST v.1.1.
• An EGFR exon 19 deletion and/or an exon 21 (L858R) substitution mutation.
• BDX004 Positive Label.
• Have received no prior systemic chemotherapy, immunotherapy, targeted therapy, or biologic therapy for metastatic NSCLC. Subjects may have previously been treated with postoperative adjuvant chemotherapy for early stage lung cancer or chemo radiotherapy for locally advanced disease provided this was completed at least 6 months prior to enrollment. No prior EGFR TKI therapy is allowed for any stage of NSCLC.

You may not qualify if:

• History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent or erlotinib.
• History of known brain metastases.
• Prior treatment with any other investigational drug or biologic agent within 5 half lives prior to randomization, or any investigational device within 2 weeks prior to randomization.
• Any unresolved toxicity from previous radiation therapy.
• Significant cardiovascular disease, including:
• Echocardiogram (ECHO) or multiple gated acquisition (MUGA) showing left ventricular ejection fraction of less than 55%.
• Cardiac failure New York Heart Association class III or IV.
• Myocardial infarction, severe or unstable angina within 6 months prior to randomization.
• History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation).
• Significant thrombotic or embolic events within 3 months prior to randomization (significant thrombotic or embolic events include but are not limited to stroke or transient ischemic attack).
• Any uncontrolled or severe cardiovascular disease.
• History of prior malignancy within 3 years prior to randomization (except for adequately treated non-melanoma skin cancer, carcinoma in situ of the breast or cervix, superficial bladder cancer, or early stage prostate cancer, without evidence of recurrence).
• Radiographic evidence of interstitial lung disease.

Sponsors & Collaborators

• AVEO Pharmaceuticals, Inc.: lead
• Biodesix, Inc.: collaborator

Study Sites (47)

UCSF Fresno

Fresno, California, 93701, United States

Location

Torrance Memorial Medical Center

Redondo Beach, California, 90277, United States

Location

Boca Raton Regional Hospital Lynn Cancer Institute

Boca Raton, Florida, 33486, United States

Location

University of Miami Sylvester Comprehensive Cancer Center Deerfield Beach

Deerfield Beach, Florida, 33442, United States

Location

Kaiser Permanente Hawaii

Honolulu, Hawaii, 96819, United States

Location

Cancer Center of Acadiana

Lafayette, Louisiana, 70503, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Valley Medical Group

Paramus, New Jersey, 07652, United States

Location

Queens Hospital Cancer Center

Jamaica, New York, 11432, United States

Location

Aultman Hospital

Canton, Ohio, 44710, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

UPMC Cancer Center Cancer

Pittsburgh, Pennsylvania, 15232, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

North Coast Cancer Institute

Coffs Harbour, New South Wales, 2450, Australia

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Townsville Hospital

Douglas, Queensland, 4814, Australia

Location

Icon Cancer Care

Southport, Queensland, 4215, Australia

Location

Princess Alexandra Hospital

Wolloongabba, Queensland, 4102, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5043, Australia

Location

Eastern Health

Box Hill, Victoria, 3128, Australia

Location

Frankston Hospital

Frankston, Victoria, 3199, Australia

Location

Ballarat Oncology and Haematology

Wendouree, Victoria, 3355, Australia

Location

Tuen Mun Hospital

Tuenmen, N.T, Hong Kong

Location

Queen Mary Hospital

Pok Fu Lam, Hong Kong

Location

AO G.Rummo

Benevento, 82100, Italy

Location

Policlinico S.Orsola Malpighi

Bologna, 40138, Italy

Location

Istituti Ospitalieri di Cremona - Oncologia

Cremona, 26100, Italy

Location

U.O.C. Oncologia

Lucca, 55100, Italy

Location

IRCCS Ospedale S.Raffaele

Milan, 20132, Italy

Location

Fondazione Salvatore Maugeri

Pavia, 27100, Italy

Location

IRCCS Istituto Clinico Humanitas

Rozzano MI, 20089, Italy

Location

Ospedale Treviglio-Caravaggio

Treviglio BG, 24047, Italy

Location

John Hopkins Singapore International Medical Center

Central Singapore, 308433, Singapore

Location

National Cancer Centre

Singapore, 169610, Singapore

Location

Korea University Guro Hospital

Guro-gu, Seoul, 152703, South Korea

Location

Chungbuk National University Hospital

Chungcheongbuk-do, 362-711, South Korea

Location

Chonnam National University Hwasun Hospital

Jeonnam, 519-763, South Korea

Location

Severance Hospital, Yonsei Uni

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Chung Shan Medical University

Taichung, 40201, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Cheng Kung University

Tainan, 70403, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Taipei Medical University

Taipei, 11696, Taiwan

Location

Chang Gung Medical Foundation

Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ficlatuzumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The Sponsor terminated Study AV-299-14-206 before enrollment was completed, effective 14-Sep- 2016, after determining that enrollment of subjects was much lower than expected, and that timely completion of the study was not feasible.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: AVEO Pharmaceuticals, Inc.

Clinical@aveooncology.com

(857) 400-0101

Study Officials

• Michael N Needle, MD

  AVEO Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 17, 2014
• Study Start: November 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: October 22, 2020
• Results First Posted: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (8); KR (5); AU (10); HK (2); TW (7); SG (2); US (13)